Prevalence of FGFR2b Protein Overexpression in Advanced Gastric Cancers During Prescreening for the Phase III FORTITUDE-101 Trial
Issued Date
2025-01-01
Resource Type
eISSN
24734284
Scopus ID
2-s2.0-85216831186
Pubmed ID
39854659
Journal Title
JCO Precision Oncology
Volume
9
Rights Holder(s)
SCOPUS
Bibliographic Citation
JCO Precision Oncology Vol.9 (2025)
Suggested Citation
Rha S.Y., Zhang Y., Elme A., Pazo Cid R., Alacacioglu A., Ziogas D.C., Shitara K., Ranceva A., Nemecek R., Santoro A., Calderon C.A., Korphaisarn K., Davis T., Zahlten-Kuemeli A., Conn C., Tan M., Honeycutt H., Wainberg Z.A. Prevalence of FGFR2b Protein Overexpression in Advanced Gastric Cancers During Prescreening for the Phase III FORTITUDE-101 Trial. JCO Precision Oncology Vol.9 (2025). doi:10.1200/PO-24-00710 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/104257
Title
Prevalence of FGFR2b Protein Overexpression in Advanced Gastric Cancers During Prescreening for the Phase III FORTITUDE-101 Trial
Author's Affiliation
North Estonia Medical Centre
Siriraj Hospital
Yonsei Cancer Hospital
Humanitas University
İzmir Kâtip Çelebi Üniversitesi
Fundación Cardiovascular de Colombia
School of Medicine
Vilniaus Universitetas
Masaryk University
Humanitas Research Hospital
Hospital Miguel Servet
Harbin Medical University
National Cancer Center Hospital East
David Geffen School of Medicine at UCLA
Amgen Incorporated
Roche Tissue Diagnostics
Siriraj Hospital
Yonsei Cancer Hospital
Humanitas University
İzmir Kâtip Çelebi Üniversitesi
Fundación Cardiovascular de Colombia
School of Medicine
Vilniaus Universitetas
Masaryk University
Humanitas Research Hospital
Hospital Miguel Servet
Harbin Medical University
National Cancer Center Hospital East
David Geffen School of Medicine at UCLA
Amgen Incorporated
Roche Tissue Diagnostics
Corresponding Author(s)
Other Contributor(s)
Abstract
PURPOSE Fibroblast growth factor receptor 2 isoform IIIb (FGFR2b) protein overexpression is an emerging biomarker in gastric cancer and gastroesophageal junction cancer (GC). We assessed FGFR2b protein overexpression prevalence in nearly 3,800 tumor samples as part of the prescreening process for a global phase III study in patients with newly diagnosed advanced or metastatic GC. METHODS As of June 28, 2024, 3,782 tumor samples from prescreened patients from 37 countries for the phase III FORTITUDE-101 trial (ClinicalTrials.gov identifier: NCT05052801) were centrally tested for FGFR2b protein overexpression by immunohistochemistry (IHC) and had evaluable results. FGFR2b positivity was defined as both any % tumor cells (TC) and ≥10% TC exhibiting moderate-to-strong (2+/3+) membranous FGFR2b staining. Prevalence was analyzed across patient and sample characteristics. RESULTS FGFR2b protein overexpression at any % and ≥10%, 2+/3+ TC positivity was 37.8% (1,428/3,782 [95% CI, 36.2 to 39.3]) and 16.2% (612/3,782 [95% CI, 15 to 17.4]), respectively. Of any %, 2+/3+ TC-positive tumors, 42.9% (612/1,428 [95% CI, 40.3 to 45.4]) were FGFR2b ≥10%, 2+/3+ TC positive. FGFR2b prevalence was not notably different within multiple patient and sample characteristics examined (age, sex, collection method [biopsy v resection], collection site, location of primary tumor, and geographic region). CONCLUSION As of the data cutoff date, we report the largest prevalence assessment of FGFR2b protein overexpression in GC with more than one third (37.8%) of patients with GC exhibiting FGFR2b protein overexpression (any % TC, 2+/3+) by a validated IHC assay. Approximately 16% of patients had FGFR2b protein overexpression in ≥10% of TC. FGFR2b prevalence was similar across geographic regions and within defined patient and sample variables regardless of the level of expression.